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LONDON (AP) — Britain's medicines regulator has authorized the world's first gene therapy treatment for sickle cell disease, in a move that could offer relief to thousands of people with the crippling disease in the U.K. The agency approved the treatment for patients with sickle cell disease and thalassemia who are 12 years old and over. Casgevy is currently being reviewed by the U.S. Food and Drug Administration; the agency is expected to make a decision early next month, before considering another sickle cell gene therapy. Millions of people around the world, including about 100,000 in the U.S., have sickle cell disease. Scientists believe being a carrier of the sickle cell trait helps protect against severe malaria.
Persons: , Helen O'Neill Organizations: Medicines and Healthcare Regulatory Agency, Vertex Pharmaceuticals, CRISPR Therapeutics, Helen O'Neill of University College London, Medicines, U.S . Food, Drug Administration, Associated Press Health, Science Department, Howard Hughes Medical Institute’s Science, Educational Media Group, AP Locations: Europe, CRISPR, South Asian, Britain, U.S, Africa, India, Eastern
CNN —The United Kingdom has become the first country to give regulatory approval to a medical treatment involving the revolutionary CRISPR gene editing tool. The treatment, made by Vertex Pharmaceuticals, is administered by taking stem cells out of a patient’s bone marrow and editing a gene in the cells in a lab. “Modifying the stem cells from the bone marrow of the patient avoids the problems associated with immune compatibility, i.e. The release from the MHRA did not say how much the treatment would cost, but it’s likely to be expensive. CRISPR-Cas9 has had a major impact on biomedical research, clinical medicine and agriculture and is widely used in labs around the world.
Persons: , , Julian Beach, , — Emmanuelle Charpentier, Jennifer A, Doudna —, Casgevy, Alena Pance, ” Pance, Cas9, Jiankui Organizations: CNN, country’s Medicines, Healthcare, Agency, Beta, Vertex Pharmaceuticals, US Food and Drug Administration, University of Hertfordshire, Science Media Centre Locations: United Kingdom, South Asian
CNN —Britain’s health agency is warning the public not to buy pre-filled pens claiming to contain the weight loss drugs Ozempic and Saxenda without a prescription, after a small number of people were hospitalized. Ozempic is used to treat adults with type 2 diabetes, and is used off-label for weight loss. More than 350 potentially fake Ozempic pens have been seized since January of this year, according to the MHRA. The agency has also received reports that patients have obtained fake Saxenda pens in the UK through “through non-legitimate routes.”No fake weight-loss pens were seized before January 2023, the agency says. The maker of both drugs, Novo Nordisk, told CNN Thursday that it is aware that counterfeit pens are being circulated.
Persons: Ozempic, ” Allison Schneider, Dr, Sanjay Gupta, Alison Cave, ” Ozempic, , Meg Tirrell Organizations: CNN, Medicines, Healthcare, Agency, Novo Nordisk, , “ Novo Nordisk, General Pharmaceutical Council, Get CNN, CNN Health, European Medicines Agency, European Union Locations: Ozempic, “ Novo, Novo, Germany, Europe
Homeland Security, as well as companies that help identify counterfeit products such as Israel’s BrandShield. Fake weight-loss drugs will be a key focus in the agency’s annual counterfeit medicines report, due next year, the official said. “We have counterfeit products and stolen products,” the official said. "We will look online and if we find something that infringes (obesity drug trademarks) we'll get it taken down,” said Yoav Keren, BrandShield CEO. When a consumer buys those fakes, “what you get are expired drugs, counterfeit drugs, or nothing,” he added.
Persons: George Frey, Eli Lilly, BrandShield, Novo’s Ozempic, , Jim Mancuso, Mancuso, Europol, Novo, Lilly, , Ozempic, Yoav Keren, MHRA, Eli, Mounjaro, Patrick Wingrove, Aurora Ellis Organizations: Novo Nordisk, Pharmacy, REUTERS, Novo Nordisk’s, Pharmaceutical Security Institute, drugmakers Novo Nordisk, Europol, Interpol, U.S . Homeland Security, U.S . Food, Drug Administration, U.S . Department of Homeland, Coordination Center, PSI, Medicines, Healthcare, Agency, Health Organization, Ireland’s, Products Regulatory Authority, Reuters, Thomson Locations: Provo , Utah, U.S, America, Europe, Germany, Egypt, Russia, North America
Boxes of Tecentriq from Genentech are seen at the Huntsman Cancer Institute at the University of Utah in Salt Lake City, Utah, U.S., July 22, 2022. REUTERS/George Frey/File Photo Acquire Licensing RightsAug 29 (Reuters) - Britain's state-run national health service will be the first in the world to offer an injection that treats cancer to hundreds of patients in England which could cut treatment times by up to three quarters. The treatment is currently offered by transfusion to NHS patients with a range of cancers, including lung, breast, liver and bladder. NHS England said it expected the majority of around 3,600 patients starting the treatment of atezolizumab every year in England to switch onto the time-saving injection. But added that patients receiving intravenous chemotherapy in combination with atezolizumab may remain on the transfusion.
Persons: George Frey, Dr Alexander Martin, atezolizumab, Marius Scholtz, Genentech, Roche, Farouq Suleiman, Sandra Maler Organizations: Huntsman Cancer Institute, University of Utah, REUTERS, Medicines, Healthcare, Agency, Foundation Trust, Roche Products, Thomson Locations: Genentech, Salt Lake City , Utah, U.S, England, West Suffolk
Packages of the weight-loss drug Wegovy from the pharmaceutical company Novo Nordisk lie on the sales counter in a Danish pharmacy. U.K. health authorities on Wednesday said they are reviewing obesity and diabetes drugs like Novo Nordisk 's Wegovy and Ozempic after some patients who took the treatments reported thoughts of suicide or self-harm. The MHRA said the review includes all obesity and diabetes drugs available in the U.K. Aside from Ozempic and Wegovy, it includes Novo Nordisk's other weight loss drug Saxenda. Other diabetes drugs like AstraZeneca 's Bydureon, Eli Lilly 's Trulicity and Sanofi 's Lyxumia are also included in the probe. Novo Nordisk said in a statement that it received a review request from the MHRA on Monday.
Persons: MHRA, Eli Lilly, Sanofi Organizations: Novo Nordisk, Nordisk, Medicines, Healthcare, Agency, CNBC, European Union, AstraZeneca, Reuters Locations: Danish, U.S, Novo
Saxenda is Novo's older GLP-1 drug and has lower effectiveness than its newer obesity treatment Wegovy, which contains semaglutide. Novo told Reuters it had received a request on Monday from the MHRA about the agency's review of potential suicidal and self-harming thoughts related to GLP-1 drugs. The MHRA said AstraZeneca's GLP-1 drug for type 2 diabetes, called exenatide and marketed as Bydureon, was also included in the review. The MHRA said that two other GLP-1 drugs, Sanofi's (SASY.PA) lixisenatide and Eli Lilly's (LLY.N) dulaglutide, were also included. It is also investigating GLP-1 drugs for possible risk of thyroid cancer.
Persons: Novo, AstraZeneca's GLP, lixisenatide, Eli Lilly's, Sanofi, Eli Lilly, liraglutide, Alison Cave, Novo's, MHRA, Ozempic, GLP, Maggie Fick, Josephine Mason, Mark Potter, Jane Merriman Organizations: Novo Nordisk, European Union, The Medicines, Healthcare, Agency, Reuters, AstraZeneca, European Medicines Agency, Thomson Locations: Britain, Europe, United States
A South Korean COVID-19 vaccine recently authorised in Britain is administered by injection, not sprayed into the sky from aircraft, as social media posts falsely claim. Some social media users have since been saying that SKYCovion will be sprayed on people from aircraft in a possible misinterpretation of the vaccine’s name (here). However, the vaccine is not based on mRNA and is administered through intramuscular injection, according to the MHRA and SK bioscience. SKYCovion is not an mRNA vaccine but has a traditional protein-antigen design. The SKYCovion vaccine authorised in Britain is injected intramuscularly, not sprayed from the sky.
Persons: chemtrails, Read Organizations: South, SK bioscience, GlaxoSmithKline, GSK, SK Chemicals, Britain’s Medicines, Healthcare, Agency, Twitter, ” SK bioscience, Reuters Locations: Britain, South Korean
The offer of COVID vaccination for very young children is voluntary and specifically targeted to children who are most at risk from COVID, according to the government’s April announcement of the new policy. After Britain’s Joint Committee on Vaccination and Immunisation (JCVI) recommended that young children in clinical risk groups should be offered COVID vaccination, some social media users responded with outrage. JCVI ADVICEThe UK advice does not include all young children. In fact, the prioritisation of COVID-19 vaccination for clinically vulnerable children explains higher mortality rates seen during the pandemic among vaccinated children as compared with unvaccinated children (here and here). There is no evidence the vaccine is unsafe for infants and young children, according to experts and health regulators.
There is no evidence that tools used for cervical cancer screenings are cancerous, despite a video circulating online warning about the sterilisation process of test utensils. A controlled amount of the gas ethylene oxide (EO), a carcinogen, is used to sterilise medical instruments, but the process is safe, experts told Reuters. There is no evidence, however, that its use in cervical screening sterilisation processes is cancerous. Guidance from the World Health Organization (WHO) shows EO is used in the sterilisation process for speculums in line with international standards (here). The use of ethylene oxide in the sterilisation process for cervical cancer screening utensils is safe and strictly regulated.
Women who got pregnant during Pfizer’s COVID vaccine trials did not have an unusual rate of miscarriage, experts said as they responded to an online video. This is a miscarriage rate of 14%, which is within the “normal” or expected rate of miscarriage per pregnancy, Male said. They also said there is no evidence of impact from COVID-19 vaccines on fertility. Pfizer started a global trial of pregnant women in February 2021. There is no evidence that COVID-19 vaccines affect fertility and pregnancies during Pfizer’s COVID vaccine trials did not have an unusual rate of miscarriage.
March 21 (Reuters) - Britain's health regulator said on Tuesday it would introduce new measures for faster and easier approval and execution of clinical trials in the country. The move comes months after an industry report showed that the number of annual clinical trials started in Britain dropped by 41% between 2017 and 2021, posing a "clear and serious threat" to its reputation as a clinical research destination. "This overhaul of the clinical trials legislation will ... help to streamline approvals by removing granular and duplicative regulatory requirements," Marc Bailey, Chief Science and Innovation Officer at the Medicines and Healthcare products Regulatory Agency (MHRA) said. An application review will need to be completed within 30 days, while a maximum of 10 days will be given for a decision to be granted, the regulator said. Reporting by Radhika Anilkumar in Bengaluru; Editing by Vinay DwivediOur Standards: The Thomson Reuters Trust Principles.
Mouth cancer rates in Britain have been rising for two decades, with an all-time high of diagnoses likely a result of lifestyle factors, oral health experts told Reuters. This is contrary to claims shared online that COVID swab tests have caused an increase in oral cancer. One social media user spreading the falsehood here wrote: “Mouth cancer has hit an all time high! The Oral Health Foundation cites tobacco, alcohol and human papillomavirus (HPV) as the most common causes of mouth cancer (here). Oral cancer rates in Britain have been rising for at least two decades and there is no evidence a record high number of diagnoses are a result of COVID-19 swabs.
A poster masked as an advert and featuring a photo of a man’s head shattering falsely alleges that COVID-19 vaccines have been officially recognized as the cause of 31,570 psychiatric disorders in the UK. However, no association between COVID-19 vaccines and any psychiatric disorder has been found, an MHRA spokesperson told Reuters. The spokesperson added: “We have closely monitored the safety of the COVID-19 vaccines since the beginning of the UK vaccination programme. Reuters previously addressed claims that the UK’s Yellow Card scheme shows confirmed side effects of COVID vaccines here, here and here . No link has been found between COVID-19 vaccines and psychiatric disorders, according to the MHRA.
Millions of people have viewed a BBC News interview with a British cardiologist who used the broadcast to spread misinformation about COVID-19 vaccines. Malhotra cites the British Heart Foundation (BHF) for reporting 30,000 excess cardiovascular deaths “during the pandemic or since the pandemic”. A BHF spokesperson told Reuters that there were indeed 30,000 excess deaths involving ischaemic heart disease (IHD) in England between March 2020 and August 2022. Reuters has addressed similar claims linking COVID-19 vaccines with excess mortality (here, here and here), cardiac arrests (here, here and here), and other heart issues. Experts say the 30,000 excess cardiovascular deaths reported since the beginning of the pandemic are due to COVID-19 infection and issues with healthcare services.
He suffered a cardiac arrest moments after making a tackle and had to have his heartbeat restored on the field (here). In the UK, Dr Steven Cox, chief executive of charity Cardiac Risk on the Young (CRY), also told Reuters via email that sudden cardiac death in young people “is sadly not a new phenomenon”. The authors also noted that this was “likely... a significant underestimate” of the true incidence of cardiac death in the young. Another study published in 2022 by PLOS medicine found acute COVID-19 was associated with a 5.8x increased risk of cardiovascular disease, including a 6.4x increased risk of atrial arrythmias in the month after infection. Experts say there is no research that shows a link between COVID-19 vaccines and athletes collapsing or dying from sudden cardiac arrest.
Group A Streptococcus (GAS) is the name for bacteria that can cause infections like strep throat, scarlet fever and impetigo. However, the 2014 study examined different bacteria and found that while their numbers increased following the nasal flu vaccine, that did not lead to increased bacterial disease. A recent UK study has also found that while infections of influenza itself be linked to increased cases of Group A Strep, the nasal vaccine is associated with a reduction in bacterial infections. But it did not investigate group A strep bacteria; rather, the study investigated Streptococcus pneumoniae and Staphylococcus aureus, which Mina said in an email, are “very different” pathogens to group A strep. A 2014 study does not show the nasal spray flu vaccine causes Group A Strep.
“The LAIV vaccine used in the UK does not contain Streptococcus A,” an MHRA spokesperson told Reuters via email. The bacteria are not listed in the ingredients for Fluenz Tetra (bit.ly/3HesXo4), which is also marketed in the U.S. as fluMist. “Group A strep is not used at any stage of the development of the nasal flu vaccine. The vaccine does not contain Group A strep,” Pollard said via email. The MHRA and AstraZeneca told Reuters that group A strep is not an ingredient in the Fluenz Tetra vaccine, and two independent experts said there are no reports of contamination.
REUTERS/Clodagh Kilcoyne/File PhotoLONDON, Dec 6 (Reuters) - Britain's health regulator on Tuesday authorised a COVID-19 vaccine for infants as young as six months, opening the door for vaccinating the country's youngest children once the UK's Joint Committee on Vaccination and Immunisation (JCVI) agrees. Whether the vaccine is eventually deployed in this age group depends on a recommendation from the JCVI, which advises UK health departments on which shots should be used as part of the national vaccination programme. The vaccine is tailored for use in this age group - it is a lower dose version than the one used in children aged five to 11 years. U.S. officials rolled out this version of the Pfizer-BioNTech shot for the same age group earlier this year. Months ago, EU regulators also endorsed the use of COVID vaccines made by Pfizer-BioNTech and Moderna (MRNA.O) for under-fives.
UK approves Pfizer-BioNTech's COVID booster targeting BA.4/5
  + stars: | 2022-11-09 | by ( ) www.reuters.com   time to read: +1 min
Nov 9 (Reuters) - Britain's health regulator on Wednesday approved a COVID-19 booster from Pfizer Inc (PFE.N) and partner BioNTech SE (22UAy.DE) targeting the Omicron BA.4 and BA.5 sub-variants and the original coronavirus strain. The UK's Medicines and Healthcare products Regulatory Agency (MHRA) said the vaccine was approved for use as a booster dose in people aged 12 years and older after it was found to meet safety, quality and effectiveness standards. "All approved COVID booster vaccines help to improve the protection obtained from earlier doses of the vaccine and help give longer-term protection against getting seriously ill from COVID-19," according to the MHRA. Pfizer and BioNTech last week said their so-called bivalent COVID-19 vaccine tailored for BA.4/5 produced a strong antibody response in older adults than the original shot after one month, and in October said it generated a strong immune response. Reporting by Pushkala Aripaka in Bengaluru; Editing by Shinjini Ganguli and Shounak DasguptaOur Standards: The Thomson Reuters Trust Principles.
В Великобритании не выявили воздействия алкоголя на прививки от COVIDУченые Соединенного Королевства не выявили отрицательного воздействия алкоголя на прививки от коронавирусной инфекции. К этому вывову пришли в Агентстве по регулированию лекарственных средств и товаров медицинского назначения (MHRA), пишет RTVi со ссылкой на издание The Telegraph. Таким образом, отмечает издание, регулятор ответил на многочисленные вопросы пользователей соцсетей королевства, которые были обеспокоены возможным негативным эффектом от совмещения алкогольных напитков и вакцинации от COVID-19. В частности, британцы предполагали, что есть смысл воздержаться от употребления алкоголя в течение двух недель после прививки. Производители препаратов также не указывали на возможность какого-либо негативного эффекта, пишет The Telegraph.
Organizations: Агентство по регулированию лекарственные средства и товаров медицинского назначения () Locations: Telegraph, Великобритания, Соединенное Королевство
În același timp, EMA nu consideră necesar să fie refuzat vaccinul, menționând că beneficiile vaccinării cu AstraZeneca depășesc totuși considerabil riscurile administrării lui. În prezent, aproximativ 34 de milioane de persoane au primit deja vaccinul AstraZeneca în Uniunea Europeană. În următoarele patru săptămâni, Belgia va administra vaccinul AstraZeneca doar persoanelor în vârstă peste 56 de ani. Italia recomandă utilizarea preferențială a vaccinului AstraZeneca persoanelor cu vârsta peste 60 de ani, a declarat președintele Consiliului Superior al Sănătății, Franco Locatelli, după anunțul făcut de EMA. Pe 16 martie, Organizația Mondială a Sănătății a declarat vaccinul AstraZeneca sigur și a recomandat utilizarea lui în continuare.
Persons: Paolo Corradini, Britanie, June Raine, Ea, Franco Organizations: Uniunea Europeană, Societății, Consiliului Superior al Sănătății, Organizația Mondială a Sănătății Locations: Belgia, Italia, Oxford, prospect
По состоянию на конец марта в Великобритании зафиксировано 79 случаев редкого образования тромбов после вакцинирования от коронавируса препаратом компании AstraZeneca, умерли 19 привитых. В целом же первую дозу COVID-прививки вакциной AstraZeneca получили около 20 миллионов жителей Соединенного Королевства. Так, согласно статистике Агентства, серьезный риск от вакцинации среди возрастной группы до 29 лет составляет 1,1 случая на 100 тысяч человек. В связи с этим MHRA не рекомендует использовать препарат британско-шведской компании AstraZeneca и Оксфордского университета среди людей моложе 30 лет. Напомним, в Британии первую дозу вакцины от коронавируса получили 60% взрослого населения, две дозы - 10,4% граждан.
Organizations: Агентство по контролю за лекарственными средствами и изделиями медицинского назначения (), Агентство, Оксфордский университет Locations: Великобритания, Соединенное Королевство, Британия
В Великобритании Оксфордский университет приостановил испытание вакцины COVID-19, разработанной с помощью AstraZeneca, на детях и подростках, поскольку ожидает получения дополнительных данных о проблемах со свертыванием крови у взрослых, получивших данный препарат. "Из-за выявления тромбов у взрослых после прививки вакциной AstraZeneca принято решение приостановить тестирование на детях и подростках", - заявил представитель Оксфордского университета профессор Эндрю Поллард. Он подчеркнул, что в ходе педиатрического клинического исследования не было выявлено каких-либо осложнений. Возобновление испытаний возможно после получения дополнительной информации от Агентства по регулированию лекарственных средств (MHRA) о случаях тромбоза, которые были зарегистрированы у взрослых. Ранее университет сообщил, что в рамках этого исследования планируется привлечь 300 добровольцев в возрасте от 6 до 17 лет из Великобритании.
Persons: Эндрю Поллард Organizations: Оксфордский университет, Агентство по регулированию лекарственных средств () Locations: Великобритания
Şapte persoane vaccinate cu serul AstraZeneca au murit în urma formării de cheaguri de sânge în Marea Britanie, dintr-un total de 30 de cazuri identificate până acum, a anunțat Agenţia britanică de reglementare a medicamentelor şi produselor medicale, potrivit AFP, preluată de Agerpres. "Analiza noastră aprofundată asupra acestor rapoarte continuă", a declarat directorul MHRA, June Raine, în comunicat, adăugând că nu a fost raportat niciun caz similar în cazul administrării vaccinului Pfizer/BioNTech. Publicând joi un aviz cu privire la efectele secundare ale vaccinurilor administrate în ţară, MHRA a subliniat că riscul formării acestui tip de cheaguri de sânge este foarte scăzut. Vaccinul AstraZeneca, dezvoltat împreună cu Universitatea Oxford, face obiectul unor suspiciuni în mai multe ţări după înregistrarea unor cazuri grave de formare de cheaguri de sânge. În urma acestora, unele ţări au decis să nu administreze serul la persoanele sub o anumită vârstă.
Persons: June Raine, MHRA Organizations: Agerpres, Universitatea Oxford Locations: ţară, Regatul Unit
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